Thermal compression therapy apparatus and system

ABSTRACT

A method for providing a combined DVT and compression therapy to a patient is provided. The method includes providing a control unit configured to condition heat transfer fluid and to selectively provide a compressed gas, providing a thermal compression device that is mountable to a select portion of the patient, and programming the control unit to supply heat transfer fluid to the thermal compression device and to supply compressed gas to the thermal compression device.

CONTINUITY DATA

This application is a continuation of, claims priority to and thebenefit of, U.S. Ser. No. 12/501,258 filed Jul. 10, 2009 and entitled“SYSTEM AND METHOD FOR THERMAL COMPRESSION THERAPY.” The '258application claims priority to and the benefit of U.S. ProvisionalApplication Ser. No. 61/134,677, filed on Jul. 10, 2008, and U.S.Provisional Application Ser. No. 61/134,676, filed on Jul. 10, 2008. Allof which are incorporated herein in their entirety.

FIELD OF THE INVENTION

A medical device and therapy system is presented. More particularly, anapparatus and system for providing combined heating or cooling andcompression therapy is presented for use, by way of general example, inreducing edema and pain and preventing deep vein thrombosis (DVT).

BACKGROUND OF THE INVENTION

Various medical devices have been developed to deliver warming therapyand cooling therapy to patients recovering from injuries or surgeries.Additionally, it is known to provide a pressurized massage therapy,sometimes referred to as external pneumatic compression (“EPC”), tothese patients. Typical recipients of these therapies are patientsrecovering from orthopedic surgeries or injuries to various areas of theanatomy, particularly legs and knee and shoulder joints. A coolingtherapy, heating therapy, and compression therapy can also be combinedwith a motion therapy in which a patient's joint is carefully and slowlymoved through its natural motion so as to maintain flexibility in thejoint. The above-described therapies have proven useful in speedingrecovery and avoiding deleterious impacts of deep vein thrombosis amongother benefits.

In typical therapeutic arrangements an external control device providesa mechanical pumping and circulation force as well as an automatedcontrol of the pneumatic forces. Fluids from the control device arepassed through flexible tubes which are then directed to a core to bewrapped around the area to receive therapy. In this manner heatedfluids, chilled fluids, and/or air pressure can be administered to theinjured area when the core is applied to or wrapped around the patient'sbody. Arrangements of this type are described in U.S. Pat. No.5,989,285; and US Published Patent Application Publication No.2008/0058911, both of which are incorporated herein by reference todescribe the general level of knowledge held by persons skilled in theart.

Nevertheless, the systems and methods described in the prior artcontinue to suffer from various shortcomings and are in need ofimprovement. One such shortcoming relates to the high cost associatedwith the core portion of the thermal compression therapy apparatus. Thecore portion, that portion of the apparatus that is wrapped around anarea of the patient's body (a knee joint for example) is generally anexpensive item. It comprises various tubings and channels thatdistribute the fluids through the core so that they will surround thearea to be treated. However, the core necessarily comes into contactwith the patient. Thus, the core can easily become contaminated withblood and other discharges and fluids emitted by the recovering patient.Also, good hygiene practices also call for the sterilization of eachcore after a treatment if the core is to be reused. However, given thesomewhat delicate nature of the materials and structures containedwithin the core a sterilization process is not effective. Given the costof the core, throwing each core away after a single use is an expensiveoption. Thus, it would be desired to find a way to easily reuse cores sothat a single core can be used multiple times before it needs to bediscarded.

Further, the core structure itself suffers from various limitations inthe present design and is in need of improvement. As previouslydescribed, a patient's joint, for example the knee joint, can begradually flexed during a treatment. This movement of the jointnecessarily flexes the core that is wrapped around the joint. Duringsuch therapies there is a tendency within the core to fold and obstructportions of the core that is repeatedly being bent. The cores can thensuffer from malfunction or poor performance (even distribution offluids) as various tubings are obstructed. There exists a need toovercome this shortcoming in current core designs.

An additional need for improvement relates to the heating and coolingtherapy applied to the patient. In current methods there is no directway to determine the skin temperature of the patient in that area wherethe patient is receiving therapy. The skin is typically covered by thecore. However, that is an important item of data to assure that thepatient's body is not being overheated (burned) or overly chilled (frostbitten). Elderly patients or patients with severe trauma may suffer froman inability to sense temperature extremes; thus it falls upon theattending technician, nurse, or other professional to maintain a propertemperature. While the temperature exiting from the control machine cansometimes be programmed there is needed a way to confirm that thetemperature at the patient also corresponds to that temperature. Hence,it would be desired to provide a core that enables a quick, easy, andreliable detection and confirmation of the patient's skin temperaturewhere covered by the core.

Hence there has been identified a need to provide an improved therapycore and related system for providing warming therapy, cooling therapy,and compression therapy. It would be desired that the improved system orapparatus allow for multiple uses. It would further be desired that theimproved system or apparatus provide an improved function, both withrelation to fluid distribution and with respect to temperaturedetection. Further, there is a need that the improved Thermalcompression therapy apparatus and system be adapted for use with presentcontrollers and pneumatic devices. Finally, there is a need for animproved therapy core to provide a robust and strong performance whileat the same time providing cost advantages over presently known systemsand methods.

SUMMARY

An apparatus and system for compression and thermal therapy ispresented. In a first aspect of, by way of example only, a combinedheating, cooling, and compression therapy system is provided. The systemis configured for automated use with a controller. The therapy system isalso particularly designed for easy use with multiple patients. Thetherapy system comprises a reusable core through which a separatecompression apparatus and a heating/cooling apparatus are positioned.The core can be placed in a disposable outer cover. The disposable coveris typically the outer portion of the system that would come intocontact with a patient's body. Thus, the outer cover can comprise animpermeable layer such that blood and other bodily fluids cannot passthrough the cover and contact the core. In one aspect, the outer covercomprises an opening such that the core can be easily passed through theopening and into an interior volume of the cover, and the interiorvolume of the cover is designed to closely hold the core in a desiredposition. The outer cover, which comes into contact with the patient,can comprise a temperature nodule attached to a surface for monitoringthe temperature of the patient's skin. When a treatment session iscompleted, the core can be removed (and later reused), and the outercover can be disposed.

In accordance with a further aspect, and still by way of example only,there is provided an improved therapeutic system for providing acombination of compression therapy and cold and heat therapy. The systemcomprises a core having two separate channels for providing cold andheat and compression therapy; a cover for receiving the core; and a skinsensitive temperature node attached to the core cover. The therapysystem can further be configured such that the cover defines an interiorvolume and an exterior region. The cover comprises an opening such thatthe core can be positioned within the interior volume of the cover bypassing through the opening. Further, the cover can comprise a hook andloop attachment means (Velcro® type fastener) disposed proximate to theopening and configured to permit the opening to be opened and closed.The temperature node measures skin temperature as by way of athermometer or thermocouple. In one aspect a visual color codedthermometer is used.

Other independent features and advantages of the Thermal compressiontherapy apparatus and system will become apparent from the followingdetailed description, taken in conjunction with the accompanyingdrawings which illustrate, by way of example, the principles of theinvention.

DETAILED DESCRIPTION OF THE FIGURES

These and other features of the invention will become more apparent inthe detailed description in which reference is made to the appendeddrawings wherein:

FIG. 1 is overhead plan view one aspect of a thermal compression therapyunit adapted for use with a patient's knee, showing a cover and a coreconfigured for receipt by the cover;

FIG. 2 is an overhead plan view of the cover of FIG. 1, illustrating aclosing means;

FIG. 3 is an overhead plan view of the cover of FIG. 1, illustratingstraps and receiving areas;

FIG. 4 is an overhead plan view of the core of FIG. 1;

FIG. 5 is a front perspective view of one embodiment of a control unit;

FIG. 6 is a rear perspective view of the control unit of FIG. 5;

FIG. 7 is a partial cut away side perspective view of the control unitof FIG. 5, illustrating a reservoir and a power supply;

FIG. 8 is a side perspective view of a thermal compression therapysystem in use on a patient's knee;

FIG. 9 is a diagrammatical view of the a thermal compression therapysystem, illustrating various types of thermal compression units;

FIG. 10 is an overhead plan view of one embodiment of a thermalcompression unit adapted for use on the foot of a patient;

FIG. 11 is a side perspective view of the thermal compression unit ofFIG. 10, showing one method of installation onto the foot of thepatient;

FIG. 12 is a side perspective view of a coupler for use with a thermalcompression system; and

FIG. 13 is a top perspective view of the coupler of FIG. 12.

DETAILED DESCRIPTION OF THE INVENTION

The present invention can be understood more readily by reference to thefollowing detailed description, examples, drawing, and claims, and theirprevious and following description. However, before the present devices,systems, and/or methods are disclosed and described, it is to beunderstood that this invention is not limited to the specific devices,systems, and/or methods disclosed unless otherwise specified, as suchcan, of course, vary. It is also to be understood that the terminologyused herein is for the purpose of describing particular aspects only andis not intended to be limiting.

The following description of the invention is provided as an enablingteaching of the invention in its best, currently known aspect. To thisend, those skilled in the relevant art will recognize and appreciatethat many changes can be made to the various aspects of the inventiondescribed herein, while still obtaining the beneficial results of thepresent invention. It will also be apparent that some of the desiredbenefits of the present invention can be obtained by selecting some ofthe features of the present invention without utilizing other features.Accordingly, those who work in the art will recognize that manymodifications and adaptations to the present invention are possible andcan even be desirable in certain circumstances and are a part of thepresent invention. Thus, the following description is provided asillustrative of the principles of the present invention and not inlimitation thereof.

As used throughout, the singular forms “a,” “an” and “the” includeplural referents unless the context clearly dictates otherwise. Thus,for example, reference to “a core” can include two or more such coresunless the context indicates otherwise.

Ranges can be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another aspect includes from the one particular value and/orto the other particular value. Similarly, when values are expressed asapproximations, by use of the antecedent “about,” it will be understoodthat the particular value forms another aspect. It will be furtherunderstood that the endpoints of each of the ranges are significant bothin relation to the other endpoint, and independently of the otherendpoint.

As used herein, the terms “optional” or “optionally” mean that thesubsequently described event or circumstance may or may not occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not.

Referring now to FIG. 1, one aspect of a combined thermal compressiontherapy apparatus or system is presented. The thermal compression unitcomprises a core 110 and cover 120. While the core 110 and cover areshown in an exploded arrangement in FIG. 1, in usage, the core can beassembled with the cover 120 as explained further herein. The corecomprises at least one first channel 130 and at least one secondchannel. The channels 130, 140 can be connected by tubing 150.Generally, the cover defines an interior volume 160 for receiving thecore and an exterior region 122. In one aspect, the exterior region 122of the cover comprises an impermeable surface which is generally thesurface of the cover that comes into contact with a patient.

As would be understood by a person skilled in the art, liquid tubing andgas (or air) tubing can be connected to a supply machine or control unit200 that supplies liquid and gas materials to the core via the tubing150. In the case of liquid tubing, a fluid can be heated or chilled to adesired temperature. In one aspect, the fluid comprises distilled water,and can also comprise distilled water and alcohol. This fluid is thendirected through liquid tubing (typically having both an inlet and anoutlet tubing) so as to circulate the fluid through the channels andthereby to provide heating or chilling therapy to a patient. Thechannels 130, 140 can comprise a series of baffles or other flowdirecting structures to distribute the fluid to the desired zones orsections of the core 110. In one aspect, a wide distribution of fluid isprovided to avoid significant temperature gradients between one sectionor area of the core to another. In addition, gas tubing can receive agas fluid (such as air) also directed from the supply machine or controlunit 200. A separate network of channels distributes gas through thecore. The pressure of the gas can be controlled and varied so as toprovide a rhythmic pulsing of pressure around the patient's body wherethe core is positioned. Thus, for example, in the treatment of a knee,the rhythmic cycling of gas pressure increases and decreases the airpressure in the core 110 around the knee to assist with circulationamong other desired benefits. Thus, it will be appreciated that the gasnetwork of channels can be separate from the liquid network of channelsin the core so that each material provides its function; the liquidprovides temperature therapy and the gas provides a pressure therapy.While all this is going on, the patients body, such as a knee, can alsobe receiving a motion therapy, such as rhythmically straightening andflexing the knee joint. Thus, thermal compression units can beconfigured so as not to interfere with any possible flexion therapy.Additionally, while the aspects described above include providingpressure using compressed gas, it is also contemplated that othersubstances could be used to provide the desired compression.

Referring now to FIGS. 1, 2, and 3, in one aspect of thermal compressionunit 100, the apparatus comprises a temperature nodule 170. In thisaspect, the temperature nodule 170 is a temperature sensitive structure.It can, for example, comprise aspects such as a thermometer, athermocouple connected to a read out (typically positioned on thecontrol unit), or a visual color-coded read out attached to atemperature sensitive structure. In another aspect, the temperaturenodule comprises both a temperature sensitive section and a displaysection wherein the display provides a user readable indication enablingan attending technician or professional to quickly and easily determinetemperature.

In one exemplary aspect, the nodule can be disposed on the thermalcompression unit 100 such that a temperature-sensitive portion of noduleis positioned proximate to the skin of a patient when the apparatus isdisposed on the patient for therapy. Thus, in one aspect, thetemperature-sensitive portion of nodule can also be positioned on theexterior surface of the cover that is designed to be in contact with thepatient's skin. However, as can be appreciated, a read-out section canbe placed on exterior surface of the cover because it is typically thesurface that is visible for observation by an attendant. If necessary,wires or leads can also be used to connect any portion of temperaturenodule to other devices or support structures such as a power source, adigital read out, etc. In one aspect, the system can record thetemperature of the patient's skin at various intervals.

One advantage of an apparatus having a temperature nodule 170 relates tothe nodule providing an accurate temperature reading on the patient'sskin that generally lies under the cover 120 and overall apparatus. If atemperature in a heat therapy rises too high, there is a danger ofburning the patient. Conversely, if the temperature falls too low, thereis a danger of frostbite. Even when these two extremes do not occur, itis desirable to determine what the temperature of the patient's skin isas opposed to just the temperature of the fluids within the core as itis the actual skin temperature that is important in judging theeffectiveness of a therapy.

Referring again to the figures, one aspect of the thermal compressionunit comprises a tubing-cover section 124. The tubing-cover section 124can be a unitary portion of the cover, for example and not meant to belimiting. A portion of the cover can be designed to extend from the mainbody of the cover to provide protection to the liquid tubing and the gastubing. In operation, when the core is disposed within the interiorvolume 160 of the cover, the liquid tubing and gas tubing can extendfrom the interior volume through an aperture within cover that isdesigned to allow the tubings 150 to extend to the exterior region ofthe cover. In this way, the liquid tubing and gas tubing can makeconnections with supply tubings that originate in the control unit. Thetubing-cover portion of the cover 120 can provide an extension ofmaterial that covers and protects the tubings from damage or contactwith skin surfaces. In some aspects, the tubing-cover portion of thecover can comprise padding or protective material to cushion and protectthe liquid tubing, the gas tubing, and other connecting tubings.

It is noted that the combined thermal compression unit 100 can take anydesired shape to conform to specified portions of the patients anatomy.In one aspect, as can be seen in the figures, the illustrated shape hasproven useful for treatment of the human knee. In usage, the uppersection 116 can wrap around an area generally above the knee joint whilethe lower section 114 can wrap around an area generally below the kneejoint. The middle section generally follows a neck 112 or smallercross-sectional width which allows for the upper section and lowersection to readily wrap around the leg portions while also allowing theknee joint to flex. As can be appreciated, the thermal compression unitcan be shaped to contour almost any extremity, including, but notlimited to feet, ankles, hands, wrists, and the like. The thermalcompression unit can also be configured to affix to the extremity insuch a way as to permit contraction and flexion or it can be configuredto restrict movement altogether.

In a further aspect of the thermal compression unit, a bridge support180 can be provided, as a separate structure or comprised in either thecore 110 or the cover. The bridge support 180 is generally positionedproximate to the area of middle section. At this area, as can beappreciated, the channels 130, 140 in the core necessarily cross througha neck 112 area of reduced cross sectional width as the fluids pass fromlower section 114 to upper section 116 and vice versa. As can beappreciate, folding of the core can cause pinching of the channels,which, in turn, can cause the flow of gas or fluid to be impeded. Thus,the presence of a bridge support can prevent this from occurring.Additionally, the repetitive flexing of the patient's joint can tend toinduce a fold in the flexible plastic material of the channels; thisfold or bend can then lead to obstruction within the channels just asmight happen when a drinking straw is folded in half. The bridge supportprovides a flexible but firm reinforcing material that helps preventchannels from being pinched or closed. Bridge support 180 tends toinhibit an obstructing fold from forming in channels by providing asupportive structure.

Referring again to FIGS. 1, 2, and 3 the cover is described in furtherdetail. In one aspect, the cover 120 is constructed of a low costmaterial such that cover can be used as a throw away item. The cover isgenerally configured to closely receive the core. Thus, the cover can bea shield against contamination of the core by blood or other humandischarge. The cover can comprise an impermeable surface, for example,that can be constructed of a material that prevents this kind ofcontamination of the core 110. However, the cover allows the function ofthe core to continue unimpeded by easily transmitting heating, cooling,and pressure. Thus, after a usage has taken place, the technician ornurse can throw away the cover and then reuse the core in a subsequenttreatment.

Referring specifically to FIG. 3, the cover is shown having fasteningstraps 190 and receiving areas 192 attached to both the upper sectionand the lower section. In one aspect, the fastening straps 190 andreceiving areas 192 can comprise a reciprocal hook and loop attachmentmeans e.g., VELCRO® fabric). Thus, the cover can be wrapped around aportion of the patient's body, and then the fastening straps andreceiving areas can be brought into contact. In this manner the covercan be securely attached to the patient. The cover can also be securedin this manner when the core is disposed within cover.

As has been previously mentioned, the core can be assembled with thecover by passing the core through the opening 126 of the cover and intothe interior volume of the cover. The opening 126 can comprise a closuremeans 128 for securing the opening in a closed position to securely holdthe core within interior volume. In one aspect, the closure means 128comprises a hook and loop reciprocal attachment fabric such as VELCRO®fabric; however, other aspects can use other known kinds of fastenerssuch as zippers, buttons, clips and the like.

In one aspect, a control unit is presented that is adapted to providethe thermally controlled fluid and compressed gas for multipletherapeutic modalities. The control unit for providing these selectivefeatures can be enclosed within a single chassis design capable ofproviding the described modalities. In another aspect, the control unitcan comprise a separate temperature control unit and a pressure controlunit, or it can comprise a single control unit 200 housing bothmodalities. This selective versatility provides financial andmanufacturing incentives in that the simple design selectively canprovide an industrial, medical, or electro-optic version that producesonly thermally controlled liquid, such as co-liquid for coolingindustrial equipment, in a configuration adaptable for otherapplications.

In another aspect, thermal therapy can be afforded to a patient toreduce swelling and edema while, in conjunction with the DVTprophylaxis, preventing blood from pooling in lower body extremities.This is particularly important after surgery when anesthesia has beeninvolved. It is well known that anesthetics often tend to reduce thewall strength of veins and, if not otherwise treated, appropriate venouspumping cannot be afforded allowing for blood pooling in clots.

In an exemplary aspect, the control unit can be provided for thermal andcompression therapy. The control unit can be adapted to be coupled tothermal and compression elements to be applied to a patient. In thisparticular aspect, the control unit can comprise a filter 210 forfiltering the compressed gas. In one aspect, the filter can beremovable. In another aspect, the filter can comprise a gas-filteringsubstance, such as woven netting, that can be attached by VELCROfasteners or the like outwardly of a perforated metal grate to allow forthe low-pressure drawing of gas therethrough. This would allow coolingof components inside the control unit 200. In yet another aspect, thecontrol unit 200 can comprise one or more fans to force gas across oneor more heat transfer assemblies (HTA).

In one aspect, a HTA can be disposed beneath a fluid reservoir 230. Thereservoir 230 can be configured to store liquid to be plumped into thefirst channel 130 via a fluid connector. In another aspect, the fluidconnector can be configured to be coupled to one or more cores. As canbe appreciated, in some aspects, a dual-fan arrangement can be used. Thefans can, for instance, be positioned to push and/or pull gas into theinterior of the control unit to distribution about the electroniccomponents so that the gas flow is both quiet and at a rate allowinginitial electronic cooling and then being available to be pushed intosections of the control unit where most heat dissipation is needed.

In yet another aspect, a power supply 220 can be disposed internallywithin the control unit, or it can be external thereto. In variousexemplary aspects, the power supply 220 can be a 500 Watt power supply.In some aspects, additional power supplies can also be used to powervarious components. For example, in addition to a 500 Watt power supply,a 65 Watt power supply can be used for components requiring less power.In some aspects, the power supplies are adapted to receive a pluralityof inputs so the control unit can be used in a plurality of countrieswithout requiring substantial reconfiguration.

A fluid pump, for example, can also be comprised within the control unitfor collecting fluid from a reservoir that has been thermally controlledby the HTA. Thermal electric cooing devices (TEC) can also be used. Inone aspect, the TECs a positioned between a heat sink and a thermaltransfer plate in a manner to provide the requisite thermal control ofthe fluid within the reservoir.

In one aspect, the control unit 200 for providing these selectivefeatures can be enclosed within a single chassis design capable ofproviding the described modalities. This selective versatility providesfinancial and manufacturing incentives in that the simple designselectively can provide an industrial, medical, or electro-optic versionthat produces only thermally controlled liquid, such as co-liquid forcooling industrial equipment, in a configuration adaptable for otherapplications. In another aspect, the size of the reservoir has beenreduced relative to a number of earlier models of thermoelectric cooler(TEC) systems such that only around 175 Watts can be needed compared to205 Watts for typical earlier systems. As such, the control unit can beconfigurable with TEC assemblies maximizing efficiency. With regard to amedical modality, thermal therapy can be afforded to a patient to reduceswelling and edema while, in conjunction with the DVT prophylaxis,preventing blood from pooling in lower body extremities. This isparticularly important after surgery when anesthesia has been involved.It is well known that anesthetics often tend to reduce the wall strengthof veins and, if not otherwise treated, appropriate venous pumping maynot be afforded allowing for blood pooling in clots.

In one aspect, a plurality of gas connectors and fluid connectors can beused to provide thermally conditioned heat-transfer fluid to a pluralityof thermal therapy devices and to provide pressurized gas to a pluralityof compression therapy devices and DVT compression devices. In someaspects, fluid connectors are provided in to facilitate circulation offluid in a closed loop in an outward bound and an inward bound flow offluid to and from the fluid reservoir 230 for thermal control. In someaspects, a single compression therapy device can be coupled to aplurality of gas connectors and the control unit can be programmedaccordingly to provide compressed gas in a sequenced manner to aplurality of cores in the compression therapy device. For example, afirst core can be inflated, followed by the inflation of a second core,which is then followed by the inflation of a third core, and so on. Thefirst core can be deflated before or after the second core is inflated,or the first core can remain inflated until all the cores are inflated.

In a further exemplary aspect, the system comprises a coupler 300configured to selectively connect the first channel 130 to the liquidsource and the second channel 140 to the compressed gas source. In thisaspect, the coupler 300 comprises a body 310 defining a first interiorpathway 320 and a second interior pathway 330. Each pathway has an inletand an outlet. The inlet 350 for the first interior pathway 320 can beconfigured to selectively couple with the first channel 130, the outlet355 of the first interior pathway 320 can be configured to selectivelycouple with the liquid source, the inlet 360 of the second interiorpathway 330 can be configured to selectively couple with the secondchannel 140, and the outlet 365 of the second interior pathway 330 canbe configured to selectively couple with the compressed gas source.

In another aspect, the body 310 of the coupler further defines a thirdinterior pathway 340 having an inlet 370 and an outlet 375. In thisaspect, the inlet 350 of the first interior pathway can be configured toselectively couple with a first port 132 of the first channel 130 andthe inlet 370 of the third interior pathway 330 can be configured toselectively couple with a second port 134 of the first channel 130.Additionally, the outlet 375 of the third interior pathway 340 can beconfigured to selectively couple with the liquid source.

As one skilled in the art will appreciate, some or all of the inlets cancomprise a male or female quick disconnect coupling. Likewise, therespective outlets can comprise a complimentary quick disconnectcoupling. In one exemplary aspect, the inlets for the first interiorpathway 320 and the third interior pathway comprise a female quickdisconnect coupling, and the outlets for the first interior pathwaycomprise a male quick disconnect coupling. Similarly, in this aspect,the inlet for the second interior pathway comprises a male quickdisconnect coupling, and the outlet for the second interior pathwaycomprises a female quick disconnect coupling.

In some aspects, the cores 110 are pressurized in accordance with themedical modality described herein and the parameters are set by theprogramming within the control boards of the control unit. Additionally,an RS232 connector for data communication with the control unit may beprovided. In other aspects, other connections can be used such as, forexample, a USB connection, or a wireless connection.

In various aspects, the control unit 200 can be used to initiate andcontrol different sequencing patterns, times, and pressures, dependingon the type of treatment desired. Various aspects allow a plurality ofparameters to be specified by a user, such as, for example, the inflatedpressure, the deflated pressure, the rate of inflation, theinflation-hold time, and the cycle time. For example, in one treatmentmodality, the control unit 200 can provide compressed gas to inflate aDVT compression device for 3-20 seconds when the DVT compression deviceis disposed on a calf. Thus, the control unit can be configured toprovide a series of timed pulses of compressed gas. The time period ofthe pulse can be more or less depending on the part of the body beingtreated. For example, a pulse width of around 0.3 seconds can bedesirable for a foot. Similarly, the inflation times may vary dependingon whether DVT compression devices located on both right and leftextremities are being inflated simultaneously or whether the inflationis being alternated between the devices. For example, an inflationperiod of 18 seconds may be desirable for simultaneous inflation whereasan inflation period of 8 seconds may be desirable when the inflation isbeing alternated. Similarly, when DVT compression devices are disposedaround a patient's right and left feet, in some situations it may bedesirable to have a wide pulse width on the order of 9 seconds whereasin other situations it may be desirable to have a narrow pulse width onthe order of 0.3 seconds. In addition, it mar be desirable to vary thecycle times in between DVT pulses. For example, in some aspects, a cycletime of 20 seconds in between DVT pulses may be desirable. Similarly, insome aspects, it may be desirable to completely deflate the DVTcompression devices in between inflations while in other aspects, it maybe desirable to keep the DVT compression devices partially inflated. Ascan be seen from the above examples, it would be desirable to have aprogrammable control unit that can be adapted to provide DVT compressionat user-specified parameters.

In another aspect, a method for providing a combined DVT and compressiontherapy to a patient is disclosed. The method comprises the steps ofproviding a control unit configured to condition heat transfer fluid andto selectively provide a compressed gas; providing a thermal compressiondevice that is mountable to a select portion of the patient; andprogramming the control unit 200 to supply heat transfer fluid to thethermal compression device within a first predetermined temperaturerange and to supply compressed gas to the thermal compression devicewithin a first predetermined pressure range. In this aspect, the thermalcompression device is in operative communication with the control unit.

As described in the various treatment modalities herein, the controlunit can be programmed to supply the heat transfer fluid and thecompressed gas to the thermal compression device in various manners. Infact, the control unit can supply more than one thermal compressiondevice. In one exemplary aspect, the heat transfer fluid and thecompressed gas are supplied to the thermal compression devicesequentially. In another aspect, the sequential supply of the heattransfer fluid and the compressed gas is repeated for a predeterminednumber of treatment applications. In still another aspect, the supply ofthe heat transfer fluid at least partially overlaps in time sequencewith the supply of the compressed gas. As need for the therapy regimen,the heat transfer fluid and the compressed gas can also be supplied tothe thermal compression device substantially simultaneously. The systemcan be adapted to the patient in multiple modalities regulated by thecontrol unit.

As described herein, the control unit can provide thermal conditioningof the heat transfer fluid to both cool and heat the thermal transferfluid, depending on the therapy desired. In one aspect, the heattransfer fluid is conditioned to a temperature of between about 37° F.and about 105° F. In a similar manner, the control unit can providecompressed gas at pressures necessary for the particular therapydesired. In one aspect, the control unit 200 can provide compressed gasto the thermal compression unit 100 at a pressure at or below about 120mm Hg. In various other exemplary aspects, the control unit can providecompressed gas at pressure at or below 100 mm Hg, at or below 80 mm Hg,at or below 60 mm Hg, at or below 40 mm Hg, or at or below 35 mm Hg. Instill another aspect, the control unit can provide compressed gas at apressure of about 25 mm Hg.

In another aspect, the control unit can be programmed to supply the heattransfer fluid to the thermal compression device for a predeterminedheating time, depending upon the therapy desired. In one aspect, thepredetermined heating time is between about 5 minutes and about 25minutes. In still another aspect, the control unit can be programmed tosupply the compressed gas to the thermal compression device for apredetermined compression time. As can be appreciated, the method canalso comprise varying the temperature of heat transfer fluid supplied tothe thermal compression unit and/or varying the pressure of compressedgas provided to the thermal compression unit. In still another aspect,the method can comprise supplying compressed gas to the thermalcompression device until it reaches a predetermined pressure and, then,allowing the thermal compression device to deflate and repeating, asnecessary. In one aspect, the predetermined pressure is 35 mm Hg.

In another exemplary aspect, the method described herein can compriseusing the thermal compression unit on one or more body parts of thepatient. For example, and not meant to be limiting, the method cancomprise using the thermal compression unit 100 on a knee of thepatient, a calf of a patient, a foot of a patient, and the like.

As mentioned herein, the method can also comprise using a plurality ofthermal compression devices, as needed for the desired therapy. As such,the control unit can be programmed to supply heat transfer fluid to thesecond thermal compression device within a second predeterminedtemperature range and to supply compressed gas to the second thermalcompression device within a second predetermined pressure range. In oneaspect of the method, the first predetermined temperature range can besubstantially the same as the second predetermined temperature range. Inanother aspect of the method, the first predetermined pressure range canbe substantially the same as the second predetermined pressure range. Asone can appreciate, the pressures and temperatures of the first andsecond thermal compression devices can also be varied.

In one embodiment, the system for a DVT and compression therapy systemcomprises a control unit comprising a processing system as describedherein. Specifically, the processing system of the control unit cancomprise a memory, configured for storing a software program, a firstpredetermined temperature range, a first predetermined pressure range,and at least one application protocol, and a processor, coupled to thememory.

In one aspect, the processor can be configured for executing thesoftware program, selectively directing the supply of a heat transferfluid at a temperature selected from the first predetermined temperaturerange, selectively directing the supply of a compressed gas at apressure selected from the first predetermined pressure range; andselectively directing the supply of the heat transfer fluid and thecompressed gas in accordance with an application protocol selected fromthe at least one application protocol. In another aspect, the processorcan be configured for directing the steps of the methods describedherein.

Although several aspects of the invention have been disclosed in theforegoing specification, it is understood by those skilled in the artthat many modifications and other aspects of the invention will come tomind to which the invention pertains, having the benefit of the teachingpresented in the foregoing description and associated drawings. It isthus understood that the invention is not limited to the specificaspects disclosed hereinabove, and that many modifications and otheraspects are intended to be comprised within the scope of the appendedclaims. Moreover, although specific terms are employed herein, as wellas in the claims which follow, they are used only in a generic anddescriptive sense, and not for the purposes of limiting the describedinvention, nor the claims which follow.

The invention claimed is:
 1. A system for utilizing compression therapyfor addressing deep-vein-thrombosis (DVT) in a patient, the systemcomprising: a control unit adapted to thermally condition aheat-transfer liquid to an adjustable temperature level and to providecompressed gas at one or more selectable pressures; a thermal therapypad adapted for the flow of the heat-transfer liquid therethrough andbeing coupled to the control unit; a compression therapy device having abladder, wherein the compression therapy device is adapted to be coupledto the thermal therapy pad, and wherein the compression therapy deviceis coupled to the control unit for receiving at least a portion of thecompressed gas to fill the bladder, and wherein the compression therapydevice is adapted to compress the thermal therapy pad against a firstportion of a first extremity of the patient; a removable outer covercomprising an impermeable layer; and a first DVT compression devicecoupled to the control unit and adapted to receive a first pulse ofcompressed gas from the control unit, the first DVT compression deviceadapted for securement to and compression of a second portion of thefirst extremity of the patient, wherein the control unit automaticallyrestricts transmitting the first pulse, in response to the compressedgas being applied to the compression therapy device.
 2. The system ofclaim 1, further comprising a second DVT compression device coupled tothe control unit and adapted to receive a second pulse of compressed gasfrom the control unit, the second DVT compression device adapted forsecurement to and compression of a portion of a second extremity of thepatient.
 3. The system of claim 1, wherein the thermal therapy pad andthe compression therapy device are integrated into a single device. 4.The system of claim 2, wherein compressed gas is provided to the firstDVT compression device during the first pulse for a user-specifiedlength of time and compressed gas is provided to the second DVTcompression device during the second pulse for a user-specified lengthof time.
 5. The system of claim 2, wherein the control unit is adaptedto provide the compressed gas to the compression therapy device, thefirst DVT compression device, and the second DVT compression device atone or more user-specified pressures.
 6. The system of claim 1, whereinthe control unit is adapted to cycle through the following: provide apulse of compressed gas to a first bladder of the compression therapydevice; provide a pulse of compressed gas to a second bladder of thecompression therapy device; provide a pulse of compressed gas to a thirdbladder of the compression therapy device.
 7. The system of claim 2,wherein the first DVT compression device and the second DVT compressiondevice are secured to select appendages of the patient.
 8. The system ofclaim 1, wherein the compressed gas provided to the thermal compressiondevice is varied based on monitoring of conditions of the patient. 9.The system of claim 1, wherein the heat transfer fluid is heated fromabout 49° F. to about 105° F. and applied to a skin area of the patient.10. The system of claim 1, wherein the heat transfer fluid is cooledfrom about 105° F. to about 49° F. and applied to a skin area of thepatient.
 11. The system of claim 1, wherein the heat transfer fluid iscooled from an ambient temperature of about 77° F. to a temperature ofabout 37° F. within a 90 minute period.
 12. The system of claim 1,wherein the control unit is adapted to provide the compressed gas at apressure in the range of about 0 to about 120 mm Hg.
 13. A thermaltherapy pad comprising: a channel for receiving a liquid; a bladder forreceiving compressed gas, wherein a control unit is configured tothermally condition the liquid to an adjustable temperature level and toprovide compressed gas at one or more selectable pressures, wherein thesecond channel is adapted to compress the thermal therapy pad against afirst portion of a first extremity, wherein a first DVT compressiondevice is coupled to the control unit and is adapted to receive a firstpulse of compressed gas from the control unit, wherein the first DVTcompression device is adapted for securement to and compression of asecond portion of the first extremity, wherein the control unitautomatically restricts transmitting the first pulse in response to thecompressed gas being applied to the bladder; and a removable outer covercomprising an impermeable layer.
 14. The thermal therapy pad of claim13, wherein a second DVT compression device is coupled to the controlunit and adapted to receive a second pulse of compressed gas from thecontrol unit, the second DVT compression device adapted for securementto and compression of a portion of a second extremity of the patient.15. The thermal therapy pad of claim 13, wherein the control unit isadapted to cycle through the following: provide a pulse of compressedgas to a first bladder of the compression therapy device; provide apulse of compressed gas to a second bladder of the compression therapydevice; provide a pulse of compressed gas to a third bladder of thecompression therapy device.
 16. The thermal therapy pad of claim 13,further comprising a temperature indicator coupled to the removableouter cover.
 17. A control unit configured to addressdeep-vein-thrombosis (DVT) comprising: a heat source to thermallycondition a liquid to an adjustable temperature level; a compressoradapted to provide compressed gas at one or more selectable pressures,wherein a thermal therapy pad is coupled to the control unit and adaptedfor the flow of the liquid there through, wherein a compression therapydevice having a bladder is adapted to be coupled to the thermal therapypad and adapted to be coupled to the control unit for receiving at leasta portion of the compressed gas to fill the bladder, and wherein thecompression therapy device is adapted to compress the thermal therapypad against a first portion of a first extremity of the patient, whereina removable outer cover comprising an impermeable layer which receivesthe compression therapy device; and wherein a first DVT compressiondevice is coupled to the control unit and is adapted to receive a firstpulse of compressed gas from the control unit, the first DVT compressiondevice adapted for securement to and compression of a second portion ofthe first extremity of the patient; and nontransitory memory configuredto store programming for automatic sequential restriction oftransmitting the first pulse in response to the compressed gas beingapplied to the compression therapy device.
 18. The control unit of claim17, wherein a second DVT compression device is coupled to the controlunit and adapted to receive a second pulse of compressed gas from thecontrol unit, the second DVT compression device adapted for securementto and compression of a portion of a second extremity of the patient.19. The control unit of claim 17, wherein the control unit is adapted tocycle through the following: provide a pulse of compressed gas to afirst bladder of the compression therapy device; provide a pulse ofcompressed gas to a second bladder of the compression therapy device;provide a pulse of compressed gas to a third bladder of the compressiontherapy device.